Schizophrenia Clinical Trial
Official title:
Treatment Engagement in Families With Substance Use and Psychosis: A Pilot Study
The purpose of this study is to evaluate Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) for families experiencing early psychosis and substance use delivered exclusively or primarily via telehealth (video conferencing).
Status | Recruiting |
Enrollment | 80 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria for Family Members: - Ages 18-70. - Having a relative who: 1. Is a client with early course psychosis (schizophrenia, schizoaffective disorder, schizophreniform, psychosis not otherwise specified (NOS), delusional disorder, brief psychotic disorder, major depression with psychosis, and bipolar disorder with psychosis (as reported by family member, clinician, or chart review)) with first onset in the past 6 years, and 2. Used alcohol or cannabis in the past 30 days and/or has no apparent immediate interest in abstinence (responding "No" to "Do you think they want to quit right now?" in reference to overall substance use). 3. Family member has concerns about the relative's substance use. - The person(s) who can best describe the client with psychosis. - At least 4 days per month contact with the client. - Access to a computer with internet or mobile phone with video conferencing capabilities. - Ability to provide written informed consent. - Speak and read English. Exclusion Criteria for Family Members: - DSM-5 moderate or severe substance use disorder in the past year. - Lifetime psychotic disorder. - History of domestic violence with the client relative that would interfere with the ability to safely follow through with the intervention plan. - Psychiatric, cognitive, or medical impairments that would interfere with the ability to follow through with the intervention plan. - Prior participation of a family member of the client in the study program. - Significant prior experience with CRAFT (e.g., having completed a CRAFT course prior to study enrollment) Inclusion Criteria for Client Relatives: - Ages 18-35. - First episode psychosis onset in the past 6 years with a Diagnostic and Statistical Manual (DSM)-5 diagnosis of affective (bipolar disorder or major depressive disorder with psychotic features) or non- affective psychosis (schizophrenia spectrum disorder) - Used alcohol or cannabis in the past 30 days and/or has no apparent immediate interest in abstinence (responding "No" to "Do you want to quit right now?" in reference to overall substance use). - They or others have concerns about the client's substance use. - Ability to provide written informed consent (or assent with their legal guardian providing informed consent) - Speak and read English. Exclusion Criteria for Client Relatives: - N/A |
Country | Name | City | State |
---|---|---|---|
United States | McLean Hospital | Belmont | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Mclean Hospital | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean readiness to change substance use | Mean readiness to cutdown/quit using [most problematic substance] for the client with psychosis using importance-confidence-readiness rulers (0 = not at all to 10 = extremely). | Baseline, mid-intervention (week 4), post-intervention (week 8) | |
Secondary | Percentage of Session Attendance | Percentage of treatment sessions attended by the client with psychosis in past 30 days. | Baseline, mid-intervention (week 4), post-intervention (week 8) | |
Secondary | Substance Use | Client Timeline Follow Back (TLFB) past 30 day substance use, urine toxicology screen for drugs of abuse. | Baseline, mid-intervention (week 4), post-intervention (week 8) | |
Secondary | Family Wellbeing: Depression | Beck Depression Inventory-II total; scores range from 0 to 63 with higher scores representing more severe depressive symptoms. | Baseline, mid-intervention (week 4), post-intervention (week 8) | |
Secondary | Family Wellbeing: Anxiety | State-Trait Anxiety Inventory-Short Form; total scores range from 6 to 24 with higher scores representing more severe anxiety symptoms. | Baseline, mid-intervention (week 4), post-intervention (week 8) | |
Secondary | Family Wellbeing: Relationship | General Happiness item on Relationship Happiness Scale; scores range from 1 to 10 with higher scores representing greater relationship happiness. | Baseline, mid-intervention (week 4), post-intervention (week 8) |
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